Clinical Data Manager II

Pharmapace; San Diego (CA); Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

Stock options

401K with company match

Health/dental/vision insurances

Holiday/vacation benefits

Job summary

Pharmapace invites qualified candidates for a Clinical Data Manager II role. The position leads data management activities across assigned studies, ensuring adherence to GCP, ICH, and company standards.

You will serve as primary contact for sponsors, vendors, and sites, manage database setup, CRF/eCRF design, validation, and ensure data integrity through queries and final closeout. The role offers growth opportunities, competitive salaries with benefits including stock options and 401K, plus a

Qualifications

• Requires associate degree with at least 4 years leading data management or 4–6 years in the field.
• BS/MS in Life Sciences or technical discipline with 3+ years data management lead exp. preferred.
• Experience managing moderate to complex projects across paper and EDC; global projects preferred.

Responsibilities

• Lead data management activities for assigned studies, ensuring GCP/ICH/company standards.
• Serve as primary contact for sponsors, vendors, and sites on data matters.
• Manage database setup, CRF/eCRF design, annotations, specs, and validation testing.

Skills

Data management

Leadership

Communication

Problem-solving

Education

Associate degree / 4 years experience

BS/MS Life Sciences

Tools

SAS

EDC

Job description

Pharmapace welcomes qualified and motivated candidates to apply for Clinical Data Manager II. Pharmapace is a fast growing and specialized consulting/outsourcing company serving the biotech and pharmaceutical companies in their clinical development programs. We offer a stimulating working environment and excellent career growth opportunity.

Key Responsibilities

• Lead and oversee all data management activities for assigned studies, ensuring compliance with GCP, ICH, and company standards.
• Serve as the primary contact for sponsors, vendors, and sites on all data-related matters.
• Manage database setup, design, and validation, including CRF/eCRF design, annotation, database specifications, and validation testing.
• Oversee data integrity and quality through query management, data listings review, and discrepancy resolution.
• Perform data management closeout activities including SAE reconciliation, medical coding, and database quality control through database lock.
• Support and/or lead internal and sponsor meetings, providing clear updates and technical guidance on data management deliverables.
• Contribute to business development activities, including participation in client meetings and proposal discussions.
• Train and mentor junior data management staff, supporting their technical and professional growth.
• Ensure adherence to project timelines, deliverables, and budget constraints, escalating risks or issues proactively.
• Maintain proper study documentation and ensure compliance with trial master file requirements.
• Contribute to process improvement initiatives and share best practices across the department.

Qualifications:

Education & Experience:

• Associate’s degree with a minimum of 4 years of data management lead experience, or equivalent 4–6 years of industry experience.
• BS/MS in Life Sciences or technical discipline with at least 3 years of data management lead experience preferred.
• Proven experience managing moderate to complex projects across both paper and EDC studies; global project experience preferred.
• Solid understanding of FDA, ICH, GCP, NDA, IND, and other regulatory guidelines.
  
• Strong knowledge of clinical data management principles and systems.
• Excellent oral and written communication skills with the ability to build rapport with sponsors, sites, and vendors.
• Strong analytical, organizational, and problem-solving skills with high attention to detail.
• Proven ability to lead data management tasks independently with minimal supervision.
• Proficiency in Microsoft Office Suite; familiarity with SAS or other programming tools a plus.
• Ability to manage multiple priorities, work effectively in a team environment, and mentor junior colleagues.
• Professional demeanor, proactive mindset, and commitment to quality and accuracy.

Pharmapace offers competitive salaries plus stock options, 401K plan with company match, health/dental/vision insurances, and holiday/vacation benefits. Pharmapace is an equal opportunity employer. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin/ancestry, age, disability, marital status, and veteran status.